Efficacy and Safety of Lanreotide Versus Placebo for Treatment of Patients With Digestive Fistulae
Phase 3
Completed
- Conditions
- Digestive Fistulae
- Interventions
- Drug: Placebo
- Registration Number
- NCT00729313
- Lead Sponsor
- Ipsen
- Brief Summary
The purpose of the protocol, is to determine whether lanreotide 30 mg is effective in the treatment of patients with digestive fistulae.
- Detailed Description
The purpose of this study is to determine whether lanreotide 30mg compared to placebo is effective on the evolution of drainage volume of digestive fistulae in the 72 hours following the beginning of treatment and on the spontaneous closure time of digestive fistulae.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
Inclusion Criteria
- Patient with pancreatic, duodenal, or small intestine fistula
- Patient with simple, externalised fistula
- Patient with fistula for which a medical conservative treatment is considered
- Patient with:
- for pancreatic fistulae: a mean drainage volume more than or equal to 100 ml/24h over 48 hours or more than or equal to 50 ml / 24h over 3 days and a concentration of amylase in the drainage fluid 3 times higher than in the serum over at least 2 or 3 consecutive days respectively,
- for duodenal and small intestine fistulae: a mean drainage volume more than or equal to 100ml/24h over 2 days
Exclusion Criteria
- Patient expected to require a surgical treatment of the fistula during the study
- Patient having uncontrolled intra-abdominal sepsis; Crohn's disease; radiotherapy lesions of the small bowel; a mesenteric vascular insufficiency; a fistula localised in cancer-infiltrated areas; a distal obstruction; an exposed fistula of the small intestine; or intra-abdominal foreign bodies.
- Patient receiving long-term corticotherapy
- Patient having received any somatostatin analogue as curative treatment of the fistula or any PRF somatostatin analogue within the previous month.
- Patient having previously undergone a transplant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Lanreotide microparticles Drug: Lanreotide 30 mg microparticle formulation One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of lanreotide 30 mg microparticle formulation every 10 days): according to the patient's treatment response at 72h For non-responders patients lanreotide will be stopped. 2 Placebo One intra-muscular injection. A (maximum) 60 day "treatment" period (6 intra-muscular injections of placebo every 10 days): according to the patient's treatment response at 72h. Non-responder patients having received placebo on the first injection should receive an open-labelled lanreotide treatment.
- Primary Outcome Measures
Name Time Method Number of patients with a reduction of fistula drainage volume > 50% of baseline at 72 hours. Fistula drainage volume on 3rd day.
- Secondary Outcome Measures
Name Time Method Pancreatic or duodenal and small intestine fistula closing rate within D60 Day 60 Number of injections received by each patient End of study Percentage of fistula recurrence during the follow-up period Duration of follow-up period for each patient is of 1 month Percentage of mortality in each group End of study Closure time of digestive fistulae will be defined by the interval between D0 (day of the first injection) and the date of spontaneous closure of the fistula. Day 60
Trial Locations
- Locations (18)
Hôpital Nord
🇫🇷Marseille, France
CHU J. Minjoz
🇫🇷Besançon, France
Hôpital Avicenne
🇫🇷Bobigny, France
Hôpital de la Cavale Blanche
🇫🇷Brest, France
Hôpital Louis Mourier
🇫🇷Colombes, France
Hôpital Henri Mondor
🇫🇷Créteil, France
Hôpital A. Michallon
🇫🇷Grenoble, France
CHU de Bicêtre
🇫🇷Kremlin Bicêtre, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
Hotel Dieu
🇫🇷Lyon, France
Scroll for more (8 remaining)Hôpital Nord🇫🇷Marseille, France